Kornimate/medical-research-clean huggingface dataset:
freeze all strategy versus fresh embryo transfer after gnrh analogue trigger

Conditions: Ovarian Hyperstimulation Syndrome; Pregnancy Related

Summary: ovarian hyperstimulation syndrome (ohss) is one of the most dangerous complications of assisted reproduction technology (art), described in approximatively 3 to 10% of stimulation cycles although an underestimation of the real incidence has been suggested. the use in clinical practice of gnrh antagonist has made it possible to perform the trigger with gnrh analogues, with the advantage of considerably reducing the risk of ohss.

the main concerns about the trigger with analogue are about obstetric outcomes, since it may increase the abortion rate (ar) and reduce the ongoing pregnancy rate (opr) due to luteal phase deficiency, and on the other hand about oocyte quality and competence. while in order to maximize the chance of pregnancy at fresh embryo transfer after gnrha trigger, several studies have focused on the importance of luteal phase support, other authors suggest that the best strategy is freeze-all: cryopreservation of all the obtained embryos and subsequent single embryo transfers. however, data about oocyte quality, retrieval rate, pregnancy rate and reduced occurrence of complications such as ohss, especially on the very first embryo transfer, are still scarce.

Eligibility criteria:
inclusion criteria: * patients undergoing art cycle with antagonist protocol stimulation and trigger with gnrh agonist * patients are believed at risk of ohss at time of trigger based on size and number of follicles developed (≥18 follicles with diameter 12 mm at induction). exclusion criteria: * hypogonadotropic hypogonadism * other art protocols * any patient that underwent freeze-all strategy in order to perform pre-implantation genetic testing (pgt) * oncological or deferring motherhood freezing procedures
prevalence of nocturnal hypoglycemia in children on a type 1 diabetes (tid) insulin regimen using a continuous glucose monitoring system (cgms)

Conditions: Nocturnal Hypoglycemia; Type 1 Diabetes

Summary: this study will help determine the frequency and magnitude of nocturnal hypoglycemia (low blood sugar at night during sleep), in children with type 1 diabetes who are on a standard insulin regimen, by using a continuous glucose monitoring system (cgms). secondary objectives include the establishment of a definition of nocturnal hypoglycemia for the cgms and for the calculation of sample size needed for future studies using cgms. nocturnal hypoglycemia (nh) can be associated with significant morbidity including seizure and coma. the investigators intend to use the cgms in a future study investigating the use of a new insulin combination aimed to decrease the frequency of nh in the pediatric population. thirty pediatric subjects with established type 1 diabetes mellitus will be asked to wear a cgms for 3 days. during this time the participants will be required to test and record self-monitored blood glucose readings at designated time periods and if they have symptoms of hypoglycemia. the comparison of these values with each other and with different previously defined values of nh will allow for a clear definition of nh to be made. a survey has also been designed to assess participant satisfaction with the cgms.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * less than 18 years of age * \>2 year duration of diabetes * on a conventional tid insulin regimen (morning and bedtime nph) for a minimum of 3 months * informed consent and assent exclusion criteria: * medical conditions other than treated hypothyroidism or asthma requiring oral glucocorticoids more than once per year * intention to move outside of cheo's catchment area within the next 4 months * more than 17 years of age and unwilling to continue receiving diabetes care at cheo until study completion * intention to switch to a different insulin regimen prior to study completion

Keywords: nocturnal hypoglycemia type 1 diabetes children adolescents cgms
buccal versus intranasal route of administration of midazolam spray in behavior management of pre-school patients

Conditions: Dental Anxiety

Summary: purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.

thirty six children fulfilling the requirements of having a dental condition that needed treatment in two dental settings, not exceeding thirty minutes each. they were randomly assigned to one of two groups, according to the treatment offered at the first visit. at the first visit, either buccal or intranasal aerosolized midazolam was administered. at the second visit the alternate route was implemented in a cross-over design with a one week washout period. vital signs were recorded at baseline and at 5 minutes interval throughout the treatment session.

Eligibility criteria:
inclusion criteria: * negative and definitely negative behavior according frankl's scale. * asa group i (normal healthy patient without systemic disease) and ii (patient with mild systemic disease) with no medical contraindication which rules out the use of midazolam. * children with at least two carious lesions requiring dental intervention in two settings of not more than 30 minute each. exclusion criteria: * children with multiple carious lesions who require treatment under general anesthesia.
a dose-finding study of jmkx003142 in treatment of renal edema

Conditions: Edema Secondary; Edema Leg

Summary: to evaluate the safety, efficacy, and pharmacokinetic characteristics of jmkx003142 administered randomly, open-label, active-controlled study in chinese renal edema patients.

jmkx003142 is an arginine vasopressin（avp）-v2r antagonist which shows a remarkable diuretic effect in healthy volunteers.in this phase 2 study ，we will observe the safety 、efficacy and pharmacokinetic（pk） characteristics about different dose levels of jmkx003142 tablets in renal edema patients. this phase 2 study is designed as a randomly, open-label, active-controlled study.

Eligibility criteria:
inclusion criteria: * patients who can fully understand the purpose and process of the study and voluntarily sign the informed consent form（icf）; * age ≥ 18 years old during screening; * diagnosed as renal edema during screening; * estimated glomerular filtration rate（egfr） ≥ 15 ml/min/1.73m2 during screening. exclusion criteria: * patients who are receiving the renal replacement therapy during screening or patients who require renal replacement therapy in the short term evaluated by the researchers; * patients who are suspected with hypovolemia; * patients with the following diseases or symptoms: acute thrombosis, diarrhea, and difficulty urinating; * patients who are unable to sense thirst or who have difficulty with fluid intake; * patients who have received arginine vasopressin-v2r blockers within 30 days prior to the screening examination; * the following laboratory indicators are abnormal: glutamic pyruvic transaminase ≥ 1.5 ×upper limit of normal, glutamic oxaloacetic transaminase ≥ 1.5 × upper limit of normal, serum sodium\> upper limit of normal, d-dimer ≥ 2 × upper limit of normal; * patients who received diuretics or treatments with diuretic effects from day-2 to randomization; * during screening, systolic blood pressure \ 160mmhg/diastolic blood pressure \>100mmhg; * patients who have a history of allergies to ≥ 3 substances, or are currently in an allergic state; * female patients who are breast-feeding or who have a positive pregnancy test result prior to receiving investigational product (imp); * sexually active males or women of childbearing potential (wocbp) who do not agree to practice birth control or remain abstinent during the trial and for 30 days after the final imp administration.

Keywords: renal edema edema due to kidney diseases
oral hydration for mild to moderate hyperglycemia in the emergency department

Conditions: Hyperglycemia

Summary: diabetes and high blood sugar are extremely common among patients presenting to us emergency departments. intravenous fluids with or without insulin are often used to treat these patients. however, simple, low-cost interventions, such oral hydration have not been studied in this context. oral rehydration may be better than no therapy at all, which is often what these patients receive in the first few hours when presenting to busy, overcrowded emergency department (ed) with long wait times, or in resource-poor environments such as developing countries. the investigators propose a study to see if oral hydration for adult patients presenting to the ed with high blood sugar i.e. finger-stick (fs) values between 250 and 500 mg/dl can help lower blood sugar at the same rate as intravenous fluids. half the patients will be given intravenous fluids per our department protocol, while the other half of the patients will be given 2 liters of water to drink over a 1-hour period. both groups will have their blood sugar measured every 30 mins for 2 hours. the investigators will analyze the data to determine if there is a statistically significant difference in blood sugar between the two groups within 2 hours.


Eligibility criteria:
inclusion criteria: * any patient, above the age of 18 years old, presenting to emergency department triage with a fingerstick glucose between 250 and 500 mg/dl exclusion criteria: * patients with evidence of dka (hyperglycemia with ketonuria and abnormal ph or bicarbonate on venous blood gas), hhs, or other critical illnesses requiring immediate medical attention (as determined by ed triage nurses), * end-stage renal disease requiring dialysis through an arterio-venous shunt or fistula, * abnormal mental status (gcs \< 15), * unstable vital signs including pulse \> 100, sbp \ 20, (or any combination of vital signs not meeting these cutoffs but deemed worrisome by the triage nurse) or unable to tolerate oral intake/actively vomiting. * patients who receive iv fluids prior to or during the study period. * patients unable to communicate in english or spanish. * jail patients will also be excluded.

Keywords: hyperglycemia hydration
a study of controlled-release carvedilol compared to immediate-release carvedilol in patients with primary hypertension

Conditions: Hypertension

Summary: the purpose of this study is to compare the efficacy of the egalet® controlled release formulation to an immediate release carvedilol tablet.


Eligibility criteria:
inclusion criteria: * have a diagnosis of mild or moderate primary hypertension * be able to tolerate a 2 week washout phase followed by a 2 week placebo run- in phase * be minimum 18 years of age exclusion criteria: * be intolerant to alfa- or beta-blockers * have secondary causes of hypertension * be taking more than two antihypertensive medications
the effect of deep breathing and transcutaneus electrical nerve stimulation on heart rate variability

Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus; Healthy Participants

Summary: this interventional study aims to investigate the effect of deep breathing (db) and transcutaneous electrical vagus nerve stimulation (tvns) on heart rate variability (hrv) in healthy participants and patients with rheumatoid arthritis (ra) or systemic lupus erythematosus (sle). hrv is used as a surrogate measure of vagal nerve tone. the study consists of three sub-projects: sub-project 1: to compare the effect of one session of db and one session of non-invasive auricular tvns on vagal nerve tone measured by hrv in healthy participants and in patients with ra and sle. the hypotheses is that db has a similar effect on hrv as non-invasive electrical tvns. sub-project 2: a dose-response study in healthy participants comparing the effect of 5, 15 and 30 minutes of db on hrv. the hypothesis was that hrv increases as a function of the number of minutes the db is performed in healthy participants. sub-project 3: to investigate the effect of the optimal dose found in sub-project 2 in patients with ra and sle measured by hrv, and to investigate its reproducibility by doing it twice.the hypothesis was that hrv increases after db in patients with ra and sle, and the effect is reproducible. in all three sub-projects the washout period will be investigated by measuring hrv three times after the intervention. we hypothesise that the effect of db and tvns on hrv decreases over time.


Eligibility criteria:
inclusion criteria: * men and women in the age range from 18 years to 85 years old. * for subproject 1 and 3 the participants must be diagnosed with either rheumatoid arthritis or systemic lupus erythematosus. * must sign and date informed consent. exclusion criteria: * lacking ability to make or understand informed consent. * medical history with psychiatric or psychological conditions which the person in charge of the research estimates will affect the participants ability to participate in the study. * furthermore participants with severe mental illness will be excluded due to the fact that severe mental illness cause decreased heart rate variability. * pregnancy. * addict or prior addict defined as abuse of hash, opioids or other euphoriant drugs. * known atrial fibrillation or atrial flutter. * known chronic lung disease.

Keywords: heart rate variability deep breathing transcutaneous vagus nerve stimulation vagus nerve stimulation breathing exercises
effects of pedals program versus lower limb strength training in diplegic cp

Conditions: Cerebral Palsy,Diplegic

Summary: cerebral palsy (cp) is a neurodevelopmental disorder is caused by damage to the developing brain and is characterized by abnormalities of muscle tone, mobility, and motor abilities. cp may only be recognized at 3-5 years of age. pediatric endurance and limb strengthening (pedals) program is important to achieve endurance, gross motor function and some measure of strength in patients with diplegic cerebral palsy. the aim of this study is to evaluate the comparative effects of pediatric endurance and limb strengthening program with lower limb strength training in diplegic cerebral palsy.

a randomized control trial will be conducted through convenient sampling. subjects will randomly allocated into two groups, group a will receive pediatric endurance and limb strengthening program, while group b will receive lower limb strength training. the duration of the treatment will be 8 weeks. goniometer, six minute walk test and gross motor function measure scale-88 will be used to as outcome measure. goniometer measures the available range of motion at a joint, six minute walk test measure cardiorespiratory or aerobic endurance, the gmfm-88 provides more descriptive information about motor function for very young children or children with more complex motor disability, data will be analyzed on spss version 27, normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.

Eligibility criteria:
* inclusion criteria: • * age between 6-12 years of age, children with cerebral palsy * ability to follow simple verbal direction * ability to walk independently with or without an assistive device for short distance (gmfcs) level 1-11 * good or fair selective voluntary motor control for at least one limb exclusion criteria: * orthopedic surgery * botulinum toxin injection within the preceding 3 months * serial casting or new orthotic devices within the preceding 3 months * initiation of oral medication that effect the neuromuscular system * significant hip, knee or ankle joint contractures * inability of unwillingness to maintain age- appropriate behavior

Keywords: cerebral palsy, endurance, strength, training, pediatric
the effectiveness of hand massage on the pain of cardiac surgery critically ill

Conditions: Pain

Summary: postoperative pain is a common phenomenon in the intensive care unit (icu) despite the multitude of efforts dedicated to promote its effective relief. mounting evidence shows that cardiac surgery icu patients experience moderate to severe pain reaching proportions as high as 74% despite the use of analgesics. the highest pain intensity is experienced in the first 24 hours post surgery when patients are still in the icu, and represents a strong predictor for the presence and severity of persistent postoperative pain. to maximize pain relief, massage has been suggested in the recent clinical practice guidelines of the society of critical-care medicine as a complementary non-pharmacological therapy in the icu given its opioid-sparing and analgesia-enhancing potential. some randomized controlled trials showed promising pain relief effects of massage when administered to cardiac surgery patients in acute care units, however, its effects on pain relief while patients are still in the icu and when pain severity is highest remain unknown. this study aims to compare the effect of three 20-minute hand massage administrations within 24 hours postop on the pain intensity (primary outcome), pain unpleasantness, pain interference, muscle tension, anxiety and vital signs (blood pressure, heart and respiratory rates) of adult intensive care unit (icu) patients post cardiac surgery versus hand holding (i.e., simple touch) and standard care. other objectives are to describe the location and quality of pain of cardiac surgery icu patients. hypothesis: patients receiving 3 hand massages within 24 hours postop will have lower pain intensity, unpleasantness and interference, muscle tension, anxiety and vital signs compared to patients receiving hand holding and to those in the standard care group.


Eligibility criteria:
inclusion criteria: * able to speak french or english * elective cardiac surgery requiring sternal incision (e.g., coronary artery bypass graft, valve replacement) * able to answer questions and self-report symptoms exclusion criteria: * previous cardiac surgery * diagnostic of cognitive or psychiatric disorder * pulmonary artery pressure \>50 mmhg * right ventricular failure * systolic left ventricular dysfunction (ejection fraction 35% or less) * body mass index \> 30 * prolonged bleeding from the chest drainage tubes (i.e., \>200 ml/h) * having mechanical blood pressure support (e.g., intra-aortic balloon pump) * receiving cardiac pacing with complete control of hr * peripheral intravenous line in the hands * suppurating/infective/inflammatory skin condition of the hands * hypersensitivity to touch.

Keywords: pain thoracic surgery massage
innove study: a study of 3 months induction with fuzeon (enfuvirtide) + optimized background (ob) versus ob alone in hiv-1 infected patients with virological failure.

Conditions: HIV Infections

Summary: this 2 arm study will assess the efficacy and safety of a new regimen of fuzeon + optimized background antiretroviral treatment, in fuzeon-naive hiv-1 infected patients with virological failure. eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + fuzeon 90mg s. c. twice daily, to determine the effect of 3 month induction with fuzeon.it will be possible for a patient to receive several additional 3 month periods with f uzeon, in the case of new virological failure. the anticipated time on study tre atment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * hiv-1 infection, with virologic failure; * on same stable haart for \>4 weeks, with viral load \>1000 rna copies/ml; * fuzeon-naive. exclusion criteria: * coinfection with hiv-2; * active opportunistic infection in 4 weeks prior to screening; * cirrhosis or severe liver failure; * severe renal disease.

Keywords: treatment experienced
does oral magnesium substitution relieve pregnancy induced leg cramps ?

Conditions: Cramps

Summary: this is a trial of treatment with tablets containing magnesium for leg cramps in pregnancy.

healthy pregnant women between 18 and 36 weeks of pregnancy suffering from leg cramps at least twice a week were treated with magnesium tablets or placebo for two weeks, 120 mg x 3 daily.

Eligibility criteria:
inclusion criteria: * pregnant women with recurrent leg cramps (at least twice a week). * no disease according to helath certificate. written participation consent must be signed. * linguistic ability demanded: norwegian as the first language. gestation length more than 17 weeks, less than 36 weeks. exclusion criteria: * twin pregnancy. * oedema. * pre-eclampsia. * magnesium supplementation beyond the trial treatment.

Keywords: pregnancy magnesium leg pain
is virtual reality a non-pharmacological premedication?

Conditions: Anxiety

Summary: preoperative anxiety of patients who will undergo septorhinoplasty surgery will be measured and their hemodynamic parameters will be recorded afterwards. then, a video will be shown to the patients through virtual reality glasses and the effect of this application on their anxiety will be investigated.


Eligibility criteria:
inclusion criteria: * asa i-ii risk group * will be operated under general anesthesia under elective conditions * going to undergo surgery for septoplasty / rhinoplasty * patients whose informed consent was read and approved exclusion criteria: * those who do not want to participate in the study * asa iii - iv-v patients * psychiatric-cognitive dysfunction * claustrophobia * patients using sedative and narcotic drugs * alcohol-drug addicts * blind or deaf patients * patients who cannot speak turkish

Keywords: virtual reality anxiety premedication
flare type self-expandable metal stent for malignant colorectal obstruction

Conditions: Colorectal Cancer

Summary: this study compares flare type self-expandable metal stent with conventional d-type self-expandable metal stent for malignant colorectal obstruction.


Eligibility criteria:
inclusion criteria: * malignant colorectal obstruction confirmed by radiologic study exclusion criteria: * bowel perforation * multiple obstruction * benign obstruction * pregnancy

Keywords: colorectal cancer stent
postoperative therapy after interposition arthroplasty in cmc1

Conditions: Thumb Osteoarthritis

Summary: in this randomized controlled trial the investigators want to investigate whether early versus late mobilisation after surgery in the first carpometacarpal joint (cmc1) leads to a faster recovery of hand function. the investigators also want to explore patients' satisfaction with the two different treatment regimes. the participants in the control group will receive the standard treatment at diakonhjemmet hospital: immobilisation of the thumb in a splint for six weeks. the participants in the intervention group will use a soft splint for six weeks, but will be instructed to remove the splint daily to perform exercises for the thumb. a total of 70 patients will be included in the study.


Eligibility criteria:
inclusion criteria: * osteoarthritis in cmc1 diagnosed by radiography and a surgeon. * planned surgery(interposition arthroplasty) in cmc1 * ability to communicate in norwegian exclusion criteria: * surgery involving other joints of the hand in addition to cmc1. * previous surgery of the same thumb. * other diseases og injuries that could influence hand function. * mental or cognitive deficit.

Keywords: osteoarthritis cmc1-joint postoperative therapy interposition arthroplasty of the thumb occupational therapy